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The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | botulinum toxin Type A (200U) |
|
| 2 | Experimental | botulinum toxin Type A (300U) |
|
| 3 | Other | placebo; botulinum toxin Type A (200U) |
|
| 4 | Other | placebo; botulinum toxin Type A (300U) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A (200U) | Biological | botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Baseline, Week 6 |
| Change From Baseline in Maximum Detrusor Pressure (MDP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Middlebury | Connecticut | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25288099 | Derived | Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7. | |
| 22965657 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A (300U) | botulinum toxin Type A (300U) |
| FG001 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
|
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|
| botulinum toxin Type A (300U) | Biological | botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor |
|
|
| Normal saline (Placebo); botulinum toxin Type A (200U) | Other | Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor |
|
|
| Normal saline (Placebo); botulinum toxin Type A (300U) | Other | Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor |
|
|
Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. |
| Baseline, Week 6 |
| Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire | Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement. | Baseline, Week 6 |
| Rio de Janeiro |
| Brazil |
| Victoria | British Columbia | Canada |
| Salouël | France |
| Milan | Italy |
| Amsterdam | Netherlands |
| Porto | Portugal |
| Singapore | Singapore |
| Pretoria | South Africa |
| Santa Cruz de Tenerife | Spain |
| Hualien City | Taiwan |
| Scunthorpe | United Kingdom |
| Sussman D, Patel V, Del Popolo G, Lam W, Globe D, Pommerville P. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2013 Mar;32(3):242-9. doi: 10.1002/nau.22293. Epub 2012 Sep 10. |
| 21798658 | Derived | Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. doi: 10.1016/j.eururo.2011.07.002. Epub 2011 Jul 13. |
| FG002 | Placebo | Normal saline (placebo) |
| COMPLETED |
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| NOT COMPLETED |
|
| Treatment Cycle 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A (300U) | botulinum toxin Type A (300U) |
| BG001 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) |
| BG002 | Placebo | Normal saline (placebo) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Intent-To-Treat, defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Number of Weekly Episodes | Baseline, Week 6 |
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| Secondary | Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Intent-To-Treat, defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Milliliters (mL) of urine | Baseline, Week 6 |
|
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| Secondary | Change From Baseline in Maximum Detrusor Pressure (MDP) | Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. | Intent-To-Treat, defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters of water (cm H2O) | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire | Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement. | Intent-To-Treat, defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Number on a Scale (Score) | Baseline, Week 6 |
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin Type A (300U) | botulinum toxin Type A (300U) | 18 | 89 | 70 | 89 | ||
| EG001 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) | 17 | 91 | 63 | 91 | ||
| EG002 | Placebo | Normal saline (placebo) | 23 | 90 | 52 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (13.0) | Systematic Assessment | Event not related to study drug |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Endocarditis enterococcal | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Bursa injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Urethral injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Urine cytology abnormal | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment | Event not related to study drug |
|
| Calculus bladder | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment | Event not related to study drug |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment | Event not related to study drug |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 40 and 64 years |
|
| Between 65 and 74 years |
|
| >= 75 years |
|
| Male |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|